Medical Device Package With Flip Cap Having A Snap Fit

ABSTRACT

A package for a medical device such as an intermittent catheter has a case which is closed at one end and open at the other end. A cap is connected to the case by a hinge to permit selectable movement of the cap between an open position, wherein access is provided to the open end of the case, and a closed position, wherein the cap prevents access to the open end of the case. A seal is connected to one of the cap and case. The seal is engageable with the other of the cap and case when the cap is closed to form a barrier that maintains a sterile environment inside the package. The seal can be repeatedly made and broken whenever the user closes or opens the cap, respectively. The case includes a pair of slots at the open end. A pair of latches are formed in the cap. The latches fit into the slots to prevent lateral forces from distorting the cap when the cap is closed.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a divisional of U.S. Nonprovisionalapplication Ser. No. 16/094,937, filed Oct. 19, 2018, which is aNational Stage of PCT International Application No. PCT/US2017/028979,filed Apr. 21, 2017 which claims the benefit of and priority to: U.S.Provisional Patent Application No. 62/326,322, filed Apr. 22, 2016; U.S.Provisional Patent Application No. 62/431,856, filed Dec. 9, 2016; U.S.Provisional Patent Application No. 62/448,748, filed Jan. 20, 2017; andU.S. Provisional Patent Application No. 62/461,635, filed Feb. 21, 2017,the disclosures of all of which are hereby incorporated herein byreference.

FIELD OF THE DISCLOSURE

This disclosure relates generally to packaging for medical devices suchas urinary catheters. More particularly, this disclosure relates tocompact catheters, such as urinary catheters, and the packaging, storingand hydrating/lubricating of such catheters.

BACKGROUND

Intermittent catheterization is a good option for many users who sufferfrom a neurogenic bladder, that is, an atonic or unstable bladderassociated with a neurological condition, such as diabetes, stroke, orspinal cord injury. Very often a neurogenic bladder is caused byconditions which may also result in diminished dexterity of the user.

Commonly, in intermittent catheterization single use, individuallypackaged, sterile catheters are used. Catheters often include a surfacetreatment that reduces friction to allow for easier and less traumaticinsertion into and through the user's urethra.

Regardless of whether a surface treatment is used or what type ofsurface treatment is used, some type of package for the catheter isrequired. In the past various kinds of packages have been used,including molded containers of assorted sizes and shapes, bags andpouches made of plastic or metal foil, and similar kinds of devicesWhile these prior art packages generally accomplish the objective ofprotecting the catheter during transport, storage and preparation foruse, they suffer from disadvantages that range from fundamental—thepackages may break open prematurely; to economic—the package designs arewasteful of material and labor; to the annoying—the packages confuseusers as to how to open them or are difficult for a user of lowdexterity to easily access the catheter, or the packages tend to spillthe hydrating medium upon opening.

Accordingly, what is needed is a catheter package that is economical tomanufacture and fill, reliable throughout its useful life, and simpleand intuitive to use. It is also desirable to have a compact packagewhich is can be discreetly carried by the user in a purse or pouch;discrete to dispose of in a waste bin; and intuitive and easy to open,particularly by a user with low dexterity. Additional desirable featuresof the package include easy removal of the catheter from the case; easyreclosing of the case after use; hygienic use; and it should be discreetand clean to carry after use.

Because users often carry intermittent catheters with them in containerssuch as purses, handbags, shoulder bags, backpacks and the like, thesealed catheter package should be capable of withstanding compressionand other forces to which such containers are typically subjected. Moreparticularly, the catheter package should remain sealed even whensubjected to such forces so as to, among other things, maintain thesterility of the catheter within the package.

Furthermore, users will often prefer to return a used catheter to theirpurse or bag for subsequent disposal. Accordingly, the catheter packageshould be capable of receiving a used catheter back in the package andthen being reclosed in a sealed and secured manner. Thus, a catheterpackage with a reliably reclosable cap would also be desired.Convenience may be further enhanced if the reclosable cap is attached tothe remainder of the package so the cap does not become misplaced duringuse of the catheter.

As described above, many users of intermittent catheters have limitedmanual dexterity that can make it difficult for them to open a packageand extract a catheter from the package. Thus, while reliable and securecapping and re-capping are a desired aspect of a compact catheter, alsodesired is the ability to easily open the package, access and extractthe catheter. Accordingly, it would be desirable to provide a catheterand catheter package wherein extraction of the catheter is made easierby presenting at least a portion of the catheter (that is not insertedinto the urethra of the user, such as the funnel) beyond an open end ofthe package when the cap is removed. Thus, the end of the funnel ispresented for easy extraction and/or for easy and hygienic attachment ofa urine collection bag, if desired.

Of course, having at least a portion of catheter or the funnel extendingbeyond the open end of the package may make the above-described sterilesealing, capping and recapping operations more difficult to achieve. Forexample, providing a cap hinge that is unobtrusive but affords an arc ofmotion for the cap that allows the cap to clear the funnel duringopening and closing movements and attain the aforementioned sealing(capping) and re-sealing (e.g., “dynamic sealing”) presents onechallenge. Still another challenge is providing a cap that can beconfigured to achieve reliable sealing over an extending portion of thecatheter (e.g., funnel) while withstanding the forces and loads to whichit may be subjected while being carried in a handbag, purse or otherreceptacle which can compromise the seal. Side loads, i.e., radial ortangential loads on the cap can be a particular problem, especially onthe portion of the cap opposite the hinge location. The catheterpackages described herein address these concerns.

SUMMARY

In one aspect, the present disclosure is directed to a catheter package,including a case having a hollow tube which is closed at one end andopen at the other end, and a cap. The package may include a hinge havingone end connected to the cap and a second end connected to said otherend of the hollow tube. The hinge permits selectable movement of the capbetween an open position, wherein access is provided to the open end ofthe hollow tube, and a closed position, wherein the cap prevents accessto the open end of the hollow tube. A seal is connected to at least oneof the cap and case. The seal is engageable with the other of the capand case when the cap is in the closed position to form a barrierbetween the cap and case that maintains a sterile environment inside thecase and cap.

In another aspect, the present disclosure is directed to a catheterpackage including a case having a hollow tube which is closed at one endand open at the other end and a cap. The package may include a hingehaving one end connected to the cap and a second end connected to theother end of the hollow tube. The hinge permits selectable movement ofthe cap between an open position, wherein access is provided to the openend of the hollow tube, and a closed position, wherein the cap preventsaccess to the open end of the hollow tube. A seal connected to at leastone of the cap and case is provided. The seal is engageable with theother of the cap and case when the cap is in the closed position to forma seal between the cap and case that can be repeatedly made and brokenwhenever the user closes or opens the cap, respectively.

In one more particular aspect, the present disclosure includes a hardplastic packaging that holds a short, hydrophilic coated catheter. Thecatheter may have a length of, by way of example only, about 91 mm ofexposed length. A funnel is attached to the catheter. The funnel may be,for example, about 40 mm long. The hard packaging enables the propertiesof vapor hydration through a hydration liner that separates a waterchamber from the hydrophilic coated catheter.

In another more particular aspect, the present disclosure is directed toa hard plastic packaging that holds a short, hydrophilic coatedcatheter. The catheter tubing may have a length of, by way of exampleonly, about 91 mm of exposed length. A funnel is attached to thecatheter tubing. The funnel may be, for example, about 40 mm long. Thehard packaging enables the properties of vapor hydration through ahydration liner that separates a water chamber from the hydrophiliccoated catheter.

In a further aspect, the present disclosure is directed to a packagethat has a hollow plastic case for receiving the catheter. The case hasa generally tubular wall closed at one end by a bottom wall. Theopposite end of the case is open and has a cap attached to it by ahinge. The cap is selectably movable between open and closed positionsin which the cap uncovers or covers the open end of the case,respectively. The cap has a pair of latches on the bottom edge thereof.A pair of slots are formed on the top of the case and define a detentbetween them. When the cap is placed in the closed position the latchesfit into the slots and engage the detent to retain the cap in the closedposition by releasably resisting vertical lifting forces on the cap.Engagement of the detent by the latches also prevents lateral forces onthe closed cap from dislodging the cap or impairing its seal.

A case insert has a lower, collet portion engaging the internal surfaceof the case's tubular wall just below the open end thereof. An upper,projection portion of the case insert extends axially upwardly from thecollet and protrudes beyond the open end of the case's tubular wall. AnO-ring is seated in a groove on the outer surface of the projection. TheO-ring is engageable with the interior surface of the cap when the capis in the closed position. The cap is configured to fit around and clearthe upstanding funnel and the projection of the case insert duringopening and closing motions of the cap. The case insert may be made of arelatively rigid material to support the O-ring in sealing engagementwith the cap even after repeated closing and opening sequences of thecap. The case insert also helps resist distortion of the location of theclosed cap on the case due to side loading of the cap, i.e., tangentialor circumferential forces on the cap that may be encountered duringstorage and transport of the package.

The lower end of the collet portion of the case insert may have aradially inwardly extending foot that engages a flange on the lower endof the funnel to limit the extent to which the catheter can be insertedinto the case. The foot is located such that the upper portion of thefunnel extends above the open end of the case when the catheter isstored in the package. Alternately, the inwardly extending foot could belocated on the case. In this configuration the funnel interacts with thecase, not the case insert.

In a further aspect, the present disclosure is directed to a case insertthat has a shortened collet portion with ribs formed around its internalsurface. The bottom edge of the collet is supported in the tubular wallof the case by a ledge.

In a still further aspect, the present disclosure is directed to apackage that has a hollow plastic tube for receiving the catheter. Thetube has a generally cylindrical wall closed at one end by a bottomwall. The opposite end of the cylindrical wall has a cylindrical ferrulewhich is open at its end and defines a rim. At least partiallysurrounding the ferrule is a collar. At least a portion of the collar isseparated from the ferrule, leaving a gap between the ferrule and thecollar. Thus, the entirety of the rim is devoid of any features thatwould interfere with a tight fit between the ferrule and a cap. The capis attached by a hinge to the collar. The cap is selectably movablebetween open and closed positions in which the cap uncovers or coversthe open end of the ferrule, respectively. The cap may have a skirtwhich engages with a mating portion of the collar to cover the ferrulecompletely. A tongue on the ferrule is engageable with a groove on theinterior of the cap to retain the cap in the closed position when thecap is pivoted onto the top of the ferrule.

In another aspect, the present disclosure is directed to a package thathas a hollow plastic tube for receiving the catheter. The tube has awall of generally rectangular cross section and is closed at one end bya bottom wall. The opposite end of the tube's wall flares outwardly toan enlarged shoulder, the top land of which defines a sealing surface. Acap is attached to the tube by a hinge which allows the cap to moveselectably between open and closed positions on the tube. The bottom ofthe cap has a sealing surface that engages that of the shoulder when thecap is closed to seal the interior of the package. The cap has mountedthereon a novel operating lever. The lever has a fulcrum attached to thecap and both an opening mechanism and a locking mechanism. The operatinglever allows easy opening and closing of the packaging containing thecatheter as well as easy access to the catheter. The package is openedby actuating a finger-sized flexible operating lever which is part ofthe cap. When the opening mechanism of the operating lever is depressed,it disengages the locking mechanism by pulling it away from the casebody due to the intrinsic stiffness and elasticity of the plastic andthe geometry of the pivot point. Actuation of the locking mechanism willalso break a tamper evident feature placed between the locking mechanismon the cap and the case. The cap and the case may be molded as twoseparate components or one component.

Once the cap and the opening mechanism are actuated, the sterile sealbetween the cap and the case is breached. This seal may be overmolded orinserted into the case. It will possibly be made out of a thermoplasticor a thermoset or a combination of both.

In another aspect, the present disclosure is directed to a package thathas a three-part container for receiving the catheter and a cap forclosing the container. The three parts of the container include ahydration liner, a case, and a sleeve. Each of these three parts isbasically an elongated, hollow tube, closed at one end and open at theother end, with the open end being selectably openable and closable bythe cap. The hydration liner fits within the case which in turn fitswithin the sleeve. The hydration liner has window openings that permithydration of a catheter stored in the liner. The cap may be either aflip cap that is removably attached to the case by a hinge, or it may bea twist-off cap that is removably attached to the case by threads. Witheither type of cap the sleeve and cap meet one another at a joint wherethe outer contours of the cap and sleeve match one another. In otherwords, the outer perimeters of the outer surfaces of the sleeve and capmatch one another. Thus, the mechanical components such as threads,flanges, lips, grooves, seals and the like are hidden under one or bothof the sleeve and cap. The matching outer contours of the sleeve and capprovide a smooth joint between the sleeve and cap and provide anaesthetically pleasing exterior appearance for the package.

In an alternate aspect, the present disclosure is directed to a packagethat has a two-part container that utilizes the case to provide thefunction of the hydration liner. The two parts of the container includea case and a sleeve. Once again each of the two parts is an elongated,hollow tube, closed at one end and open at the other end, with the openend being selectably openable and closable by the cap. The case fitswithin the sleeve. The case may have window openings that permithydration of a catheter stored in the case. The cap may be either a flipcap or a twist-off cap. The sleeve and cap meet one another at a jointwhere the outer contours of the outer surfaces of the sleeve and capmatch one another to provide an aesthetically pleasing exteriorappearance for the package.

The package(s) of the present disclosure permit a user to retrieve thecatheter from the case and re-capture it if they so wish. Once the capis locked back into its closed position the package retains its originalsealing qualities (meaning it will not leak), with a feature, such as alabel that breaks upon opening, indicating that the product has beenused. Another potential indication of use could be stress marks createdin the hinge when the user first opens the product.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a first embodiment of the package of thepresent disclosure, with the cap in the closed position.

FIG. 2 is an exploded perspective view of the package of FIG. 1 from adifferent angle, with the cap shown in the open position on the case andthe liner, case insert, O-ring, catheter tube and funnel removed fromthe case.

FIG. 3 is a rear elevation view of the package looking at the hingejoining the cap to the case.

FIG. 4 is a left side elevation view of the package of FIG. 1.

FIG. 5 is a front elevation view of the package of FIG. 1.

FIG. 6 is a front elevation view of the liner.

FIG. 7 is a side elevation view of the liner.

FIG. 8 is a top plan view of the liner.

FIG. 9 is a bottom plan view of the liner.

FIG. 10 is a perspective on an enlarged scale of a first embodiment ofthe case insert.

FIG. 11 is a front elevation view of the case insert of FIG. 10.

FIG. 12 is a left side elevation view of the case insert of FIG. 10

FIG. 13 is a rear elevation view of the case insert of FIG. 10.

FIG. 14 is a top plan view of the case insert of FIG. 10.

FIG. 15 is a bottom plan view of the case insert of FIG. 10.

FIG. 16 is an enlarged perspective view of the upper portion of thepackage assembly with the cap in the open position, showing the catheterfunnel protruding above the case insert.

FIG. 17 is an enlarged section through the upper portion of the package,taken along the line 17-17 of FIG. 1.

FIG. 18 is an enlarged section, similar to FIG. 17 but showing analternate embodiment of the case insert.

FIG. 19 is an enlarged section, similar to FIG. 17 but with a portion ofthe funnel broken away to show a further alternate embodiment of thecase insert.

FIG. 20 is a perspective view similar to FIG. 16 but showing analternate embodiment of the detent wherein the detent is attached to thecase insert instead of to the case.

FIG. 21 is an enlarged section through the package, taken along line17-17 of FIG. 1 and showing an alternate embodiment of the case insert.

FIG. 22 is a perspective view of the case insert of FIG. 21.

FIG. 23 is a perspective view of the upper portion of the packageassembly with the cap in the open position, showing an alternateembodiment of the case insert.

FIG. 24 is a section taken generally along line 24-24 of FIG. 23.

FIG. 25 is a perspective view of the upper portion of the packageassembly with the cap in the open position, showing a further alternateembodiment of the case insert.

FIG. 26 is a section taken generally along line 26-26 of FIG. 25.

FIG. 27 is a section taken generally along line 27-27 of FIG. 25.

FIG. 28 is a vertical section similar to FIG. 17 but with the cap shownin the open position and with an alternate embodiment of the caseinsert.

FIG. 29 is a vertical section taken along line 29-29 of FIG. 1 but withthe cap shown in the open position and with the case insert of FIG. 28.

FIG. 30 is a side elevation view of the case insert of FIGS. 28 and 28.

FIG. 31 is a front elevation view of the case insert of FIGS. 28 and 29.

FIG. 32 is a perspective view of an first alternate embodiment of thedisclosure, showing the upper portion of the package tube, with the capin an open position.

FIG. 33 is a longitudinal section taken along line 33-33 of FIG. 32.

FIG. 34 is a perspective view of the package of FIG. 32 from a differentangle, with the open cap and ferrule aligned.

FIG. 35 is a side elevation view of the upper portion of the package ofFIG. 32.

FIG. 36 is a vertical section taken along line 36-36 of FIG. 34.

FIG. 37 is a perspective of an entire package according to a secondalternate embodiment of the present disclosure, showing the cap in aclosed position.

FIG. 38 is a perspective of the package of FIG. 37 but with the capshown in a partially open position to expose a catheter within thepackage.

FIG. 39 is a section, on an enlarged scale, taken generally along line39-39 of FIG. 37, with the cap shown in a closed position and theoperating lever in a locked condition.

FIG. 40 is a section similar to FIG. 39 but with the operating levermoved to a release position.

FIG. 41 is a perspective view similar to FIG. 38 but on an enlargedscale showing just the upper end portion of the package.

FIG. 42 is a perspective view of a hydration liner that can be used ineither of the packages of the present disclosure.

FIG. 43 is a top plan view of the hydration liner of FIG. 42.

FIG. 44 is a side elevation view of the hydration liner of FIG. 42.

FIG. 45 is a longitudinal section through the hydration liner of FIG.42.

FIG. 46 is a perspective view of another embodiment of a hydration linerthat can be used with the packages and assemblies of the presentdisclosure.

FIG. 47 is a side elevation view of the hydration liner of FIG. 46.

FIG. 48 is a longitudinal section through an assembly of the embodimentof the package shown in FIGS. 32-36 of the present disclosure, includinga hydration liner and catheter therein.

FIG. 49 is an enlarged section of the package assembly, including theportion indicated by the circle labeled FIG. 49 in FIG. 48.

FIG. 50 is a perspective view showing a user connecting a urinecollection bag to the catheter assembly.

FIG. 51 is a perspective view illustrating that the package assembly maybe positioned in different orientations during connection to the urinecollection bag.

FIG. 52 is a perspective view showing the urine collection bag attachedto the funnel of the catheter.

FIG. 53 is a perspective view of the catheter being removed from thepackage assembly.

FIG. 54 is a perspective view of another embodiment of a packageassembly of the present disclosure.

FIG. 55 is a perspective view of a further alternate embodiment of thedisclosure, showing a catheter package with a flip cap in a partiallyopen position to expose a catheter funnel in the package.

FIG. 56 is a longitudinal section taken along line 56-56 of FIG. 55 butwith the cap moved to a closed position.

FIG. 57 is a section taken along line 57-57 of FIG. 56.

FIG. 58 is a section similar to FIG. 56, showing an alternatearrangement for a hinge connecting a case and a flip cap.

FIG. 59 is a longitudinal section through a package of a furtheralternate embodiment of the disclosure wherein the container is atwo-part structure and no catheter is shown in the package.

FIG. 60 is a view similar to FIG. 21 showing a further alternateembodiment of a liner.

FIG. 61 is a left side elevation view of yet another alternateembodiment of the disclosure wherein the flip cap is separate from thecase.

FIG. 62 is a longitudinal section through an assembly of the embodimentof the package shown in FIG. 61.

DETAILED DESCRIPTION OF THE EMBODIMENTS

The present disclosure is directed to packages for medical devices suchas intermittent urinary catheters. Such a package is shown generally at10 in FIG. 1. FIG. 2 shows the major components of the packageincluding: a case 12, a cap 14, a hydration liner 16, a case insert 18,and an O-ring 20. FIG. 2 also illustrates the product contained withinthe package 10, namely, a urinary catheter which includes cathetertubing 22 and a funnel 24 attached to one end of the tubing 22.

Details of the case 12 will now be described. The case is preferablymolded from a suitable plastic material, such as polypropylene, althoughother materials could be used. The case includes a hollow tubular wall26 which defines an axis A as seen in FIG. 19. The tubular wall 26terminates at an end wall 28 that closes the bottom of the tubular wall.The interior surface of the tubular wall may be generally cylindrical.The exterior surface of the tubular wall 26 may have either acylindrical or rectangular cross-sectional shape or the cross-sectioncould be otherwise. As shown in FIG. 1, most of the exterior surface ofthe tubular wall 26 has a generally rectangular cross-section withlarge-radiused corners 30 joining four sides 32, although as shown eventhe sides 32 are not perfectly flat as they have a slight curvature ontheir outer surfaces. Above this rectangular portion the tubular wall 26flares outwardly somewhat at a neck portion 34 to increase the diameterof the tube. The top of the neck 34 joins a cylindrical collar 36. Thecollar terminates at an open end of the tubular wall 26.

Further details of the structure of the collar 36 are best seen in FIG.16. The open end of the collar is cylindrical in shape and thus hascircular internal and external edges. Thus, the external shape in thisembodiment is circular and the external dimension would be an outsidediameter. However, other external shapes could be used and the externaldimension of a non-circular collar would not technically be a diameter.The thickness of the wall 26 creates a radial surface or top land 40 onthe open end of the collar 36. The top land 40 is the radial surface atthe greatest axial extent of the collar 36. In the orientation of thedrawings, it is the highest or topmost radial surface. The collar 36includes several features of varying axial extent. These include ashoulder 38, sloping portions 38A, 38B of the shoulder that define apair of slots 44 and 46 and a detent 48 between the slots. The shoulder38 extends arcuately about 180° and is centered near the mid-point of ahinge 42. The top land 40 at the shoulder 38 extends circumferentiallyin two directions from the mid-point of the hinge 42 and merges withgradually downwardly sloping portions 38A, 38B that join slots 44 and46. The slots 44 and 46 terminate at a detent 48. The detent has a pairof undercuts 50 on its lateral edges that define ears 52A and 52B. Thesurfaces of the undercuts 50 and ears 52A, 52B, while not solely axial,include an axial component. The top land 40 at the detent 48 has thesame height or axial location as the top land at the shoulder 38.

The hinge 42 as shown is a living hinge, but other hinge arrangementscould be used. The hinge connects to the collar 36 and the cap 14 topermit selectable movement of the cap between open and closed positions.

Internal features of the case 12 are shown in FIG. 17 and include upperand lower radial beads 54 and 56. Between the beads the internal surfaceof the neck defines a sealing surface 58. Below the lower bead 56 thereis an inwardly extending spacer 60 of limited arcuate extent on theinterior of the neck 34 at the front only.

Details of the cap 14 will now be described. They are best seen in FIG.16. The cap is hinged to the case 12 by hinge 42 and is selectablymovable by a user between a closed position and an open position. FIG.16 shows the cap in the open position. The cap 14 includes a generallycup-shaped shell 62 having a top wall 64 joined to a generallycylindrical side wall 66. The top wall 64 and side wall 66 may merge onone side of the cap to form a lip 68 that makes it easy for a user toengage the cap with a finger or thumb. Alternately, the lip 68 can beused to assist in opening the cap by placing the lip 68 in engagementwith the edge of a table or similar surface and pulling the casedownwardly. The hinge 42 is attached to the side wall 66. The side wallterminates at a bottom land 70. The bottom land is the radial surfacethat mates with the top land 40 of the collar 36. It is the portion ofthe open end of the side wall 66 having the least axial separation fromthe top wall 64. Like the top land 40, the bottom land 70 iscylindrical. Two latches 72, 74 extend from the bottom land 70 axiallyaway from the top wall 64 of the cap. When the cap is in the closedposition the latches extend or project downwardly from the bottom land70 of the cap. Each latch has a sloping edge 72A, 74A that extends froma sill portion 71 of the bottom land 70 to a crest surface 72B, 74B ofthe latch. The facing edges of the latches 72, 74 have undercuts 72C,74C that form tabs 72D, 74D and define a gap 76 in the cap between thelatches. Similarly to the undercuts 50 and ears 52A, 52B, the undercuts72C, 74C and tabs 72D, 74D include an axial component.

When the cap is closed the bottom land 70 of the cap 14 mates with thetop land 40 of the collar 36. That is, the sill 71 engages the shoulder38, and the gap surface 76 engages the top land 40 on the detent 48.Also, the sloping edges 72A, 74A engage the sloping portions 38A, 38B,and the crests 72B, 74B engage the slots 44 and 46. Finally, as the capcloses the tabs 72D, 74D of the cap snap past the ears 52A, 52B of thedetent 48 to allow the detent to end up disposed in the gap 76. That is,ears 52A, 52B of the detent end up disposed in the undercuts 72C, 74C ofthe latches 72, 74. Similarly, the tabs 72D, 74D end up disposed in theundercuts 50A, 50B of the detent 48. During closing or opening movementof the cap the tabs 72D, 74D and ears 52A, 52B interfere with oneanother but flex slightly to allow these parts to slide past one anotherin either an opening or closing direction. Thus, when the cap is closedthe cap and collar present a smooth, but interlocking external surfaceon the top of the package. Furthermore, when the cap is closed the axialcomponents of the latches 72, 74 and detent 48 end up adjacent oneanother which will prevent any lateral forces on the cap from dislodgingthe cap or degrading the seal between the cap and O-ring, as will beexplained below. By lateral forces it is meant forces in a plane roughlyparallel to that defined by the mating top and bottom lands 40 and 70 ofthe case and closed cap. This would include forces tangential to the capor forces acting on the cap in a circumferential direction. That is, therear portion of the cap is held fixed against lateral loads by the hinge42. The front portion of the cap is held fixed against lateral loads byengagement of the detent 48 with the latches 72 and 74.

Turning now to FIGS. 6-9, a hydration liner is shown generally at 16.The hydration liner is sized to fit within the case 12. The liner 16rests within the tubular wall of the case with the catheter's tubing 22(but not the funnel 24) within the liner 16. The liner defines a spacebetween the liner's exterior surface and the case's interior surfacewithin which a hydration mechanism, such as liquid water may reside.This permits hydration of the surface treatment on the catheter tubing.

The liner 16 may be a relatively rigid plastic such as LDPE or HDPE orother relevant materials. The liner has a generally hollow tube 78 whichis open at the top and closed at the bottom. At its upper end the tube78 has a seat of slightly increased outside diameter compared to theremainder of the tube 78. The seat is sized to engage the internal wallof the package case. The seat includes an upper portion 80 of maximumoutside diameter and a lower portion 82 which has a stepped down outsidediameter compared to the upper portion. The upper portion may engage aradially extending ledge on the inside surface of the case to hold theliner in place. A keyway or slot 84 is formed in the upper portion 80 ofthe seat. There are locating pads 86 at the bottom of the tube 78 whichare engageable with the internal walls of the case to fix the bottom endof the tube. A pair of flats 88 are formed on opposite side of theexterior of the tube 78. The keyway 84, locating pads 86 and flats 88help orient the liner in place during the assembly process. The walls ofthe liner tube 78 have formed therein one or more passages or windows90. The windows will be covered with a patch (not shown) of liquidimpermeable/vapor permeable material such as, but not limited to,calcium carbonate. The patches will allow passage of water vapor (forhydration of the catheter) but will block passage of liquid waterdroplets. The patch might be heat sealed around the perimeter of thewindows 90.

Turning to FIGS. 10-15, details of the case insert 18 will now bedescribed. This embodiment of the case insert has four portions orregions, a sleeve 92, a transition section 94, a collet 96 and aprojection 98. The lowest of these is the cylindrical sleeve 92. It hasa radially inwardly directed foot or flange 100 at the bottom thereof.The sleeve at its upper end joins the transition section 94. Thetransition section flares out prominently toward the front of the insertand less so to the rear. The flaring of the transition section 94results in the top of the transition section and the collet 96 having anincreased outside diameter compared to the sleeve. At the junction ofthe exterior surfaces of the sleeve 92 and the transition section 94 andat the front thereof is a T-shaped bumper 102. The bumper is engageablewith the spacer 60 in the neck 34 of the case 12 to fix the sleeve 92and transition section 94 in the case 12 in a radial direction.

The top of the transition section 94 joins the collet 96. The collet iscylindrical and fits inside the collar 36 of the case's tubular wall 26.In this embodiment the collet has a circumferential groove 104 on itsexterior surface. The groove receives an O-ring 106 (FIG. 17). TheO-ring 106 engages the sealing surface 58 in the collar 36 to preventany leakage of a hydrating medium, e.g., liquid water, from the lowerportion of the case 12.

The top of the collet 96 joins the projection 98. The projection is thatportion of the case insert 18 that protrudes above the top land 40 ofthe collar 36. Like the collet 96, the projection 98 is cylindrical andit has essentially the same inside and outside diameters as the collet.Near the top edge of the projection 98 there is a circumferential groove108 on its exterior surface. This groove receives the O-ring 20. As seenin FIG. 17, the O-ring 20 engages the internal surface of the cap's sidewall 66 to prevent any leakage of liquids from the interior of the caseinsert 18. The O-ring 20 provides a dynamic seal in that the cap can beopened and closed numerous times and each time the cap is closed theO-ring 20 will again prevent any escape of moisture from the package.

One of the advantages of the case insert is that it provides the optionof making it from a different material than that of the case. Ifdesired, the case can be made to be very stiff because the case insertmaterial is not limited by the needs of the case and cap material. Thelatter must be soft enough to produce a good living hinge. But with anentirely separate case insert, it can be made quite robust and thereforeit provides a good base for the O-ring 20. For example, the case insertcould be made of a stiff HDPE or a grade of polypropylene that is harderthan the polypropylene of the case. Alternately, the case and caseinsert could be made of the same type of polypropylene. Mounting theO-ring on the case insert also eliminates any need to place a seal orsealing material in the cap. Furthermore, greater dimensional tolerancecan be held since the case insert is a single component, as opposed tobeing part of the case, which itself is already a complex mold.

There are several alternative methods for assembling the case 12 andcase insert 18. A first method is to mold the case as an overmold on thecase insert. This would be a two shot process. The case insert itself ismolded in shot one. Then the case is overmolded around the case insertin shot two. A second method is a one shot assembly. This would be a oneshot process. The case and case insert are both made in one shot. Athird method is a separate component assembly process. In this processthe case and case insert are individually molded as separate componentsand then assembled together. That is, the case insert would be insertedinto the case during the assembly process.

FIG. 17 illustrates the interactions among the parts at the top of thecase 12. The bottom the case insert's collet 96 sits on the lower bead56 in the neck 34 of the case. The T-shaped bumper 102 engages thespacer 60 in the neck 34. The lower O-ring 106 engages the sealingsurface 58. The upper O-ring 20 engages the interior of the cap 14. Thecatheter tubing 22 is supported in the bottom of the funnel 24. Thebottom of the funnel is supported by the foot 100 of the case insert'ssleeve 92.

FIG. 18 illustrates an alternate embodiment of the case insert at 18A.This embodiment deletes the lower O-ring and the groove on the collet96A therefor. Instead of the insert-to-case seal being made by anO-ring, it is made by an interference fit between the outer surface ofthe collet 96A and the sealing surface 58 of the collar 36. Theinterference fit may be enhanced by ultrasonically welding the caseinsert 18A to the case 12.

FIG. 19 shows another alternate embodiment for a case insert 18B. Inthis embodiment both the sleeve and transition section of the previouscase inserts have been deleted. Case insert 18B has just a collet 96Band a projection 98B. The projection 98B and the O-ring 20 therein aresimilar in structure and function to the previously describedembodiment. The collet 96B is axially shorter than the collets 96 and96A. Collet 96B extends only as far as, and rests on, the upper radialbead 56 in the neck 34. Also, a series of indentations are cut on theinternal surface of the collet 96B to define a series ofaxially-extending ribs 110. The indentations reduce portions of the wallthickness which makes the part easier to mold.

FIG. 20 illustrates an alternate arrangement for a detent 48A. Thisdetent is similar to detent 48 in that it has a pair of ears, one ofwhich is seen at 52A, that are located so as to flexibly engage the tabs72D, 74D of the cap's latches 72, 74 when the cap 14 moves between itsopen and closed positions. But instead of the detent 48A being formed onthe case and extending axially, the detent 48A is attached to theexternal surface of the case insert 18A and extends radially outwardlytherefrom. There is open space underneath the detent 48A and thus thedetent is separated from the top land 40 of the case 12. The outercircumference of the detent 48A still has the same outside diameter asthe top of the collar 36 and the bottom of the cap side wall 66.Accordingly, when the cap 14 is closed the mating detent and capsurfaces present a smooth, continuous outer surface. When the cap isclosed the latches 72, 74 snap around the detent 48A with the tabs 72D,74D ending up tucked under the ears 52A, 52B so that the ears resistunintentional opening forces and retain the cap closed. However, theears and tabs will flex upon application of an intentional opening forceto allow the cap to move from the closed position to the open position.Also, while the detent 48A is shown as a single piece, it could beformed as two separate pieces with an intermediate hiatus, so long asthe positions of the ears 52A, 52B remain the same. Making the detent48A as two pieces may make each individual piece more flexible forpurposes of snapping past the moving tabs of the cap.

FIGS. 21 and 22 show another alternate embodiment for a case insert 18C.The case insert 18C lends itself to the possibility of manufacturing itand the case 12C in a one-shot molding process. However, case insert 18Ccan also be manufactured in a two-shot molding process. Or it could bemade entirely separately from the case and then the separate case andcase insert 18C are assembled together. Thus, the design of case insert18C affords complete flexibility in the choice of its manufacturingprocess. Case insert 18C is generally similar to the case insert 18A ofFIG. 18 in that it has a sleeve 92C, a transition section 94C, a collet96C and a projection 98C, with a groove 108 on the external surface ofthe projection for receiving a single O-ring 20. Case insert 18C differsfrom case insert 18A in that the external surface of the transitionsection 94C and the collet 96C closely adhere to the internal surface ofthe case's tubular wall 26C, particularly at the neck 34C and collar36C. Thus, case insert 18C does not have a piece like the bumper 102 andthe case 12C does not have a piece like the spacer 60 on the interior ofthe neck.

FIGS. 23 and 24 illustrate a first variation of the case insert 18C. Inthe embodiment of FIGS. 23 and 24 a case insert 18C-1 differs from caseinsert 18C only in that the O-ring groove 108C-1 is formed from twoseparate components. The O-ring groove is defined by upper and lowerflanges 112C-1 and 114C-1, respectively. The upper and lower flangesjoin a root 116C-1 of the groove. In this embodiment the root 116C-1 andthe lower flange 114C-1 are integrally formed during a moldingoperation. But the upper flange 112C-1 is made as a separate part andattached to the root portion 116C-1 at a later step in the assemblyprocess. It may be attached by ultrasonic welding, for example, althoughother methods could be used.

FIGS. 25-27 illustrate a second variation of the case insert 18C. In theembodiment of FIGS. 25-27 a case insert 18C-2 once again differs fromcase insert 18C only in that the O-ring groove 108C-2 is formed from twoseparate components. The O-ring groove 108C-2 is defined by upper andlower flanges 112C-2 and 114C-2, respectively. The upper and lowerflanges join a root 116C-2 of the groove. In this embodiment the lowerflange 114C-2 is integrally formed with the collet 96C-2 of the caseinsert 18C-2 during a molding operation. But root 116C-2 is not moldedwith the lower flange 114C-2. Instead, the root 116C-2 is integrallyformed with the upper flange 112C-2, with the combination root and upperflange being separate part from the lower flange. This combined root andupper flange is then attached to the lower flange 114C-2 at a later stepin the assembly process. Once again, the combined upper flange 112C-2and root 116C-2 may be attached to the lower flange 114C-2 by ultrasonicwelding, or other suitable method.

In both of the case inserts 18C-1 and 18C-2 shown in FIGS. 23-27, theend result is a case insert whose shape is the same as case insert 18C.By forming the O-ring grooves 108C-1 or 108C-2 with two separatecomponents there is no mold parting line on the root surfaces 116C-1 and116C-2.

FIGS. 28-31 show another alternate embodiment for a case insert 18D.This embodiment is similar to the case insert 18B of FIG. 19 in that ithas a collet 96D and a projection 98D, with a groove 108D on theexternal surface of the projection 98D for receiving a single O-ring 20.As with case insert 18B, the case insert 18D lacks a sleeve. However,case insert 18D does have a truncated transition section 94D. Thetruncated transition section 94D includes an annular hoop 118 that hasan elongated apron 120 on the front side thereof. The apron 120 extendscircumferentially about one quarter of the way around the hoop 118 andit merges gradually with the remainder of the hoop. The bottom edges ofthe hoop 118 and apron 120 form an opening of sufficient diameter toallow the catheter funnel 24 to move easily in and out of the package.

When installed in a case 12 the apron 120 is generally opposite andspaced from the neck 34 of the tubular wall 26 of the case 12. Thebottom edges of the hoop 118, including the apron 120 are angledinwardly from the internal surfaces of the case's collar 36 and neck 34.Thus, the hoop 118 is spaced from the case and defines a trap space 122(FIGS. 28 and 29) between the hoop and the internal surface of the case.The trap space 122 is enlarged in the area of the apron 120. The trapspace 122 will trap any loose water in a direct hydration scenario andstop unwanted spillage. That is, in a package using direct hydrationthere is liquid water in the case for hydrating the catheter. When thecatheter is removed, the hydration water could potentially leak out theopen case. A hydration liner is one way to prevent this. The case insert18D provides another way to prevent spillage of hydration water withoutusing a liner. Here the hoop 118 forms the trap space 122 which willcollect any hydration water prone to leaking out an opened container andthereby prevent spillage. It will be noted that the amount of hydrationwater in the case is not sufficient to flood the trap space 122 andspill out through the opening in the center of the case insert 18D.

One of the advantages of using one of the case inserts 18 or 18A to 18Dto mount the O-ring 20 where it engages the interior surface of the cap14 is this arrangement enables the outer contours of the cap 14 andcollar 36 to match one another. That is, the exterior shape and outerdimensions of the cap 14 and collar 36 are the same. In the illustratedembodiments the exterior shape of the top land 40 and the bottom land 70is circular and each land 40 and 70 has the same external diameter.Thus, as the cap closes on the collar the bottom land 70 of the cap'sside wall 66 meets the top land 40 of the collar 36 in facing relation.Neither the cap nor the collar overlaps the other and one does not fitinside the other. Instead the case insert's projection 98 fits insidethe cap and the cap fits right on top of the collar. This arrangementprovides a smooth, continuous contour to the exterior of the packagewhile still sealing against leakage.

Other advantages of the case insert include the fact that the caseinsert acts as a plug that stops the hydrating fluid from spilling whenthe case is opened or when the catheter is removed. The case insertcombined with the funnel keep the hydrating fluid from spilling into theinterior of the cap. Thus, the case insert maintains the hydrating fluidwhere it belongs, namely, next to the coating on the catheter. The caseinsert could also be elongated downwardly to include a gel lubricationarea. There is also the potential to add a wiping mechanism to thebottom of the case insert so as to remove any excess gel on thecatheter.

Further benefits of the case insert include the case insert acting as aseal aid. Due to its material stiffness and design, it gives extrarobustness when subject to large external forces compared to thetraditional flip cap design in which there is no projection extendingabove the open end of the case. This affords greater ease of use interms of the opening and closing force required while ensuring a sterileflip open and close seal is achievable. Also, the case insert and O-ringallow for multiple opening and closing sequences in which a vapor andliquid seal is achieved upon each closing.

An additional benefit of the case insert is the case insert can be usedas a funnel gripper. The case insert keeps the funnel in a position thatensures it will not interact with the cap when the cap is being openedor closed. The case insert allows the protrusion of the funnel above thecase when the cap is opened, thereby presenting the funnel prominentlyto the user for gripping. The case insert also gives the latch mechanismmore rigidity. Finally, the case insert assists the latch mechanism inresisting lateral forces. Due to its relative stiffness, the case insertaids in maintaining a seal with the closed cap even when the cap issubjected to lateral forces.

It can be seen that the catheter package of FIGS. 1-22 addresses theissues noted above. The shell 62 of the cap 14 surrounds an upstandingfunnel 24 when the cap is closed. The neck 34 of the case's tubular wall26 provides an enlarged diameter for the collar 36 which in turn offsetsthe vertical axes of the tubular wall 26 and the collar 36. This permitsthe catheter funnel 24 to be located closer to the hinge 42 than to thedetent 48, thereby providing clearance for the cap beyond the funnelduring opening and closing movements. At the same time, the case insert18 provides a mounting location for the O-ring that allows the O-ring tobreak and make a seal with the interior of the cap multiple times.Finally, the vertical components of the latches 72, 74 interengage withthose of the detent 48 to resist lateral loads on the cap.

A further alternate package for medical devices such as intermittenturinary catheters is shown generally at 210 in FIGS. 32-36. The upperportion of such a package is shown here. The major components of thepackage 210 are a case 212 and a cap 214. The cap is hinged to the caseand is selectably movable by a user between a closed position and anopen position. FIGS. 32-36 show the cap in the open position.

Details of the case 212 will now be described. The case includes ahollow tube 216 which terminates at an end wall (not shown) that closesthe bottom of the tube. The tube may have either a cylindrical orrectangular cross-sectional shape or the cross-section could beotherwise. The tube defines a central axis A (FIG. 36). As can be seenin FIGS. 33 and 36 the upper end of the tube 216 has an internal rib 218that protrudes inwardly from the inside surface of the tube 216. Rib 218supports the catheter funnel that will be described below in connectionwith FIGS. 48-49. Just above the rib 218 there is an internal ledge 220.The ledge is not uniform around the internal diameter of the tube 216 asthe ledge has a somewhat greater radial extent on one side of the tube,the right side as seen in FIG. 36. This provides a structure from whichthe tube flares outwardly somewhat to increase the diameter of the tubeat a neck portion 222. The neck portion 222 joins a cylindrical ferrule224. The ferrule defines a central axis B (FIG. 36) and terminates at anopen end which defines a rim 226. It will be noted that axis A of thetube 216 is laterally offset from the axis B of the ferrule 224. Thatis, axis A is closer to the cap hinge than axis B is. This isadvantageous because it places an installed catheter, and in particularthe catheter's upstanding funnel, closer to the hinge and farther awayfrom the lug (described below) of the cap. This placement of thecatheter makes it less likely that the funnel will interfere with thelug and skirt of the cap as it closes around the top of the funnel. Insome respects the ferrule can be considered part of the upper end of thetube 216. On the exterior of the rim 226 there is a small bead 228 (FIG.36) extending radially outwardly from the ferrule wall. The exterior ofthe ferrule 224 also carries a tongue 230 extending radially outwardlyfrom the ferrule wall on the side of the ferrule opposite from the cap214.

A collar 232 surrounds the exterior of the ferrule 224. However, thecollar is not concentric with the ferrule and the collar is not exactlycylindrical either. Rather, the collar has a band portion 234 thatadjoins the exterior surface of the ferrule. The band portion includes ashoulder 236. The shoulder has an enlarged top land. The shoulder 236 issomewhat below and axially spaced from the tongue 230. The shoulder andtongue have approximately the same circumferential extent. Thus, theshoulder 236 and tongue 230 define a pocket 238 between them. A pad 240is formed below the shoulder 236 and extends below the band 234 onto theneck 222 of the tube 216.

As the band 234 encircles the ferrule 224 moving circumferentially awayfrom the shoulder 236 the band gradually separates from the exteriorsurface of the ferrule to form a separate stand-off wall 242. Thestand-off wall, while generally curving around the ferrule 224, isnon-cylindrical, thereby enabling the stand-off wall to define a spaceor gap 244 (FIGS. 33 and 36) between itself and the exterior surface ofthe ferrule 224. The stand-off wall 242 includes two scalloped portions246A, 246B, each of which merges with one of a pair of ears 248A, 248B,respectively. Between the ears the stand-off wall 242 has a curved panel250. The panel has a reduced height compared to the ears 248A, 248B.With the foregoing description of the collar 232, it can be seen thatthe ferrule 224 is generally that portion of the tube 216 above the neck222 and surrounded by the collar 232.

The top edge of the panel 250 joins one end of a hinge 252, the otherend of which connects to the cap 214. The hinge 252 as shown in a livinghinge, but other hinge arrangements could be used.

Details of the cap 214 will now be described. The cap 214 includes agenerally cup-shaped external shell 254 having a top wall 256 joined toa generally cylindrical side wall 258. The top wall and side wall maymerge on one side of the cap to form a lip 259 that makes it easy for auser to engage the cap with a finger or thumb. The hinge 252 is attachedto the side wall 258. A depending skirt 260 extends from the bottom edgeof the side wall. The skirt includes curved edges 262A, 262B which matewith the scalloped portions 246A, 246B, respectively, of the collar whenthe cap is closed. This presents a smooth, but interlocking externalsurface on the top of the package when the cap is closed.

The interior of the skirt also has a lug 264 spaced inwardly from aflange 266 which is on the edge of the skirt. Together the lug 264 andflange 266 define a groove 267 between them. This groove receives thetongue 230 on the ferrule 224 when the cap 214 is closed on the ferrule.The flange 266 and/or the tongue 230 flex to permit the tongue andflange to move past one another during closing or opening. Upon closingthe flange 266 ends up in the pocket 238 next to the shoulder 236. Thissnap fit closure retains the cap 214 closed until such time as a userwishes to open the cap by pushing the cap upwardly adjacent the pad 240.

The interior of the cap is lined or partially lined with a liner 268made of relatively soft material compared to that of the cap and case.The soft liner promotes a tight seal between the cap 214 and the ferrule224. It will be noted the liner may include a sprue portion 270 throughthe top wall 256 of the cap that assists in fixing the liner in place.The open end of the liner is cylindrical so that it can fit snuglyaround the external surface of the ferrule 224 adjacent to the rim 226and immediately therebelow. The bead 228 on the rim impinges on theinternal surface of the liner 268 to further assist in making a tightseal when the cap is closed. This seal is capable of retaining anyhydration mechanism in the case. It will be noted that since thestand-off wall 242, and particularly its curved panel 250, allows all ofthe hinge connections to be remote from the ferrule 224, neither thehinge 252 nor anything else will interfere with the liner 268 contactingthe ferrule's outer surface adjacent the rim 226 when the cap is closed.The skirt 260 of the cap in the closed position engages the top edge ofthe collar 232, with the liner 268 fitting around the external diameterof the ferrule.

It will also be noted that when the cap is closed a portion of the capliner 268 will reside in the gap 244 between the ferrule 224 and thestand-off wall 242. This construction of a female cap surrounding a maleferrule when the cap is closed affords a moisture tight seal between thecap and ferrule. At the same time the cap and ferrule constructionleaves the opening at the rim 226 of the ferrule 224 unobstructed sothat the funnel of an installed catheter can extend beyond the top ofthe case. This extension of the funnel of an installed catheter beyondthe case is desirable from the standpoint of making it easy for a userto grab the funnel and extract the catheter from the case. It also makesit easier to return a used catheter to the package because the end ofthe funnel is always going to be exposed for a user's fingers to graband hold. It can be seen that the female cap defines an enclosure whichwhen closed surrounds the extending funnel portion and also permitssealing against the outside surface of the ferrule 224.

A further alternate embodiment of a package according to the presentdisclosure is shown generally at 272 in FIGS. 37-41. This package 272 insimilar to that of FIGS. 32-36 in that it has a case 274 and a cap 276hinged to the case. The cap is movable by a user between a closedposition, shown in FIGS. 37 and 39, and an open position. The cap isshown partially open in FIGS. 38 and 41, where the funnel portion 277 ofa catheter can be seen. The case 274 includes a tube 278 having a closedend 280. The tube as shown in this embodiment has a four-sidedconstruction of generally rectangular cross section, although the crosssection could be cylindrical or otherwise. The top of the tube 278 has aneck 282 portion that merges with a shoulder 284. The neck and shouldercreate an enlargement near the top of the tube. The top land of theshoulder may have a sterile seal made of TPE or silicone for engagementwith the bottom rim of the cap. The shoulder has a notch 286 formed onone side thereof. On the side of the tube opposite the notch 286 thereis a hinge 288 attached to the shoulder 284.

The cap 276 includes its own hinge element 290 (FIGS. 39 and 40) thatmay be pinned to the hinge 288 on the shoulder 284. The hinge element290 is attached to a side wall 292 of the cap 276. The top of the cap isclosed by a top wall 294. Mounted on the cap opposite the hinge element290 there is a finger-sized, flexible operating lever 296 attached tothe side wall. The lever has a fulcrum 298 (FIGS. 39 and 40) attached tothe cap. The lever includes both an opening mechanism 300 above thefulcrum 298 and a locking mechanism 302 below the fulcrum. The lockingmechanism includes a hook 304 that is engageable with the notch 286 asseen in FIG. 39. The cap is opened by depressing the opening mechanism300. When the opening mechanism of the operating lever is depressed, thelever 296 pivots about the fulcrum 298 and thereby disengages the hook304 from the notch 286 by pulling the hook away from the notch due tothe intrinsic stiffness and elasticity of the plastic. This is best seenin FIG. 40. The cap can then be tilted back about the hinges 288, 290,as seen in FIG. 41. Actuation of the locking mechanism 302 will alsobreak a tamper evident feature, such as a piece of an adhesive label(not shown), placed between the locking mechanism 302 on the cap and thecase 274.

Turning now to FIGS. 42-45, a hydration liner is shown generally at 306.The hydration liner is sized to fit within either case 212 of FIGS.32-36 or case 274 of FIGS. 37-41. The liner 306 rests in the tube of thecase with the catheter's tube portion (but not the funnel portion)within the liner. The liner defines a space between the liner's exteriorsurface and the case's interior surface within which a hydrationmechanism, such as liquid water may reside. This permits hydration ofthe surface treatment on the catheter tubing.

The liner 306 may be a relatively rigid plastic such as LDPE or HDPE orother relevant materials. The liner has a generally hollow tube 308. Atits upper end there is a seat portion 310 of slightly increased outsidediameter compared to the remainder of the tube 308. The seat portion 310is sized to engage the internal wall of the package case, as will befurther explained below. A pair of interference ribs 312 may be formedon the external surface of the seat 310. At the top edge there is a seal314. In addition to the ribs 312, the external surface of the seat 310has at its top edge a crab claw seal 314. While the ribs 312 providestability of the liner 306 while engaged with the internal wall of thepackage case, the crab claw seal 314 provides a moisture-tight sealagainst the interior wall of the package case. The walls of the linertube 308 have formed therein one or more passages or windows 316. Thewindows will be covered with a patch (not shown) of liquidimpermeable/vapor permeable material such as, but not limited to,calcium carbonate. The patches will allow passage of water vapor (forhydration of the catheter) but will block passage of liquid waterdroplets. The patch might be heat sealed around the perimeter of thewindow.

FIGS. 46 and 47 illustrate another embodiment of a hydration liner thatis shown generally at 306 a. Similar to hydration liner 306, hydrationliner 306 a is sized to fit within either of the cases shown in FIGS.32-36 and FIGS. 37-41 or any other suitable case. The liner 306 a restsin the tube of the case with the catheter's tube portion positionedwithin the liner. The upper seat portion 310 a may have a substantiallysmooth surface that is sized to engage the internal wall of the packagecase, such as by a friction fit. The upper seat portion may be held inplace by fiction fit, heat sealing, adhesive and/or any other suitablemanner of attachment. In one embodiment, the substantially smoothsurface of the seat portion 310 a may, optionally, include a detent orrecess that engages, for example, a protruding lip that may be formed onthe interior surface of the tube, such as the lip 326 shown in FIG. 49.The friction fit, heat sealing and/or adhesive between the internal wallof the package and the seat portion 310 a may provide a moisture-tightseal or the seat portion 310 a may include a seal such as the crab clawseal 314 described above. Similar to liner tube 306, the walls of theliner tube 308 a may have formed therein one or more passages or windows316 a that may be covered with a liquid impermeable/vapor permeablematerial.

The liner tubes disclosed herein may have one or more mechanisms orfeatures that assist in aligning the liner tube during the manufacturingprocess. For example, when the one or more windows 316, 316 a arecovered with a liquid impermeable/vapor permeable material, thealignment features and mechanisms may be used to orientate or align theliner tube during a process for attaching the liquid impermeable/vaporpermeable material to the liner tube. In one embodiment, the alignmentfeatures assist in aligning and holding the liner tuber during a heatsealing process for attaching a liquid impermeable/vapor permeablecalcium carbonate material to the liner tube. Such aligning mechanismsand features may also be used to transfer and orient the liner tubealong a production line. Furthermore, the case may also includealignment features, which may correspond to the alignment features ofthe liner tube, that assist in aligning the liner tube and case relativeto one another during assembly of the package so that the liner tube isin a desired orientation relative to the case. In one example, thealignment features may include one or more protrusions 313 a located atthe closed end 311 a of the liner tube 308 a. Additionally, thealignment features of the liner tube 308 a may include flat surfaceslocated on the sides of liner tube 308 a that, optionally, may betapered. In the illustrated embodiment, liner tube 308 a includes aflat, tapered surface 315 a. In other examples, the liner tube 308 a mayinclude a plurality of flat surfaces. For instance, the liner tube 308 amay include flat, tapered surfaces 315 a on opposed sides of the tube.Furthermore, the seat 310 a of the liner tube 308 a may includealignment features that include notches or cutouts 317 a. It will beunderstood that the liner tubes may include one or more of abovedescribed alignment features.

FIGS. 48 and 49 illustrate the package 210 of FIGS. 32-36 in an assemblyincluding a hydration liner 306 and a catheter 318 installed in the case212. The catheter has a funnel 320 and tubing 322 press fit into thebottom of the funnel at a central bore in the funnel. The funnel has aflange 324 (FIG. 49) extending generally radially outwardly on itsexternal surface near the bottom of the funnel. This flange 324interacts with the internal rib 218 on the internal surface of the case212 to assist in retaining the catheter 318 in the tube 216. When thecatheter is installed in the tube 216 the bottom of the funnel 320 restson the top land of the hydration liner's seal portion 310. Retention ofthe seal portion 310 in the tube 216 is aided by the interference ribs312 surrounding an inwardly protruding lip 326 which is formed on theinterior surface of the tube 216.

As shown in FIGS. 48 and 49 and explained above, upon opening of thepackage 210, the distal end 321 of the funnel 320 projects above the rim226 and extends or projects out of the opening of the package so thatthe funnel 320 may be accessed and grasped by the user to remove thecatheter 318 from the package. As also discussed above, the catheter 318is retained within the package by, for example, an interaction betweenthe internal rib 218 of case 212 and flange 324 of the funnel 320, untilthe user applies sufficient force to remove the catheter from thepackage. For example, axial movement of the catheter to move the flange324 past the rib 218. One of the benefits of this retention feature isthat the engagement between the catheter 318 and the case 212 resistsinadvertent removal of the catheter 318 so that the catheter 318 remainswithin the opened package 210 until the user actively removes thecatheter 318 for use. In other words, the retention feature prevents thecatheter 318 from inadvertently falling out of the package 210. Forconventional package assemblies wherein the catheter may inadvertentlyfall out of the package, the catheter is at risk of coming into contactwith surfaces that may contaminate the catheter which can result inincreasing the risk of infection. Thus, retaining the catheter 318within the opened package 210 until it is ready for use can assist inreducing the risk of undesired contamination. This is particularlyuseful for individuals with limited dexterity and for those who have thehabit of commencing the catheterization procedure by opening the packageand then proceeding with the other steps of the catheterizationprocedure.

Referring to FIGS. 50-53, there are some catheterization procedures thatrequire the use of a urine collection bag 330 and/or the user prefers touse a urine collection bag 330. In catheterization procedures that use aurine collection bag 330, each of the features of the catheter extendingbeyond the rim 226 of the opening of the package 210 and the catheterretention feature may provide benefits to the user.

Turning first to the retaining feature, which retains the catheter 318within the package 210 until the user applies sufficient force to thecatheter 318 to remove it from the package 210. Referring to FIG. 50,for illustrative purposes, there is shown a typical urine collection bag330 that includes a urine collection reservoir 332, such as a plasticbag, a tube 334 for the passage of urine into the collection reservoir332 and a connector 336 that connects the tube 334 to the funnel 320 ofthe catheter. In the illustrated embodiment, the connector 336 mayinclude a tapered end portion 338 which is sized to be fitted within theopening of the funnel 320 and be retained within the funnel 320 by afriction fit. Referring to FIGS. 50 and 52, to connect the urinecollection bag 330 to the funnel 320, the connector 336 is inserted intothe funnel 320 and force is applied to securely fit the connector withinthe funnel.

In conventional packages already known in the field, the user firstremoves the catheter from the package and then attaches the urinecollection bag to the funnel by grasping the funnel. While connectingthe collection bag to the funnel, the user tries to avoid contact withthe catheter tube, so as to avoid contamination thereof. This may bedifficult for users with limited dexterity and may lead to an increasedrisk of contamination.

Turning back to FIGS. 50-53, because the catheter 318 is securelyretained within the package 210 and the user does not have to beconcerned with the catheter 318 inadvertently falling out of thepackage, the user may grasp the outside of the package 210 (as opposedto only grasping the funnel) to connect the urine collection bag 330without having to first remove the catheter from the package. Theability to be able to grip the outside of the package 210 provides alarger gripping surface for the user for the user to manipulate thecatheter 318 and also reduces the risk of contamination because thecatheter 318 remains protected within the package 210 during connectionof the connector 336 and the funnel 320. Furthermore, as shown in FIG.51, after opening of the catheter package 210, the package 210 may beheld in virtually any orientation without the concern of the catheter318 falling out of the package 210. This can be beneficial to users withlimited dexterity, especially those that would need to hold the package210 upside down or with the opening in a downward orientation in orderto connect the urine collection bag 330 to the catheter funnel 320.

Regarding the distal end of the funnel 320 extending above the rim 223and out of the opening of the package 210, this feature allows the userto see the insertion of the connector 336 into the funnel 320 andvisually inspect the connection. Additionally, after the connection hasbeen made, the user may grasp the distal portion of the funnel 320extending from the opening of the package 210 to remove the catheter 318from the package 210, as shown in FIG. 53. It will be understood thatthis ability to connect a collection bag to a funnel while the catheteris still in the package applies to each of the various embodiments ofpackages shown in this disclosure.

FIG. 54 illustrates another embodiment of the present disclosure whereinthe top 340 of the package 342 has any of the features discussed above,but the bottom 344 of the package 342, which forms or defines the hollowtube that houses the catheter tube, is made from a flexible material.For example, the bottom 344 of the package 342 may be made from one ormore flexible polymeric and/or metal foil sheets. The sheet may be alaminate that includes both polymeric and metal layers. In theillustrated embodiment, the bottom 344 of the package 342 may be formedfrom a front sheet 346 and a back sheet 348 wherein the sheets 346 and348 are sealed together along the side edges 350 and bottom edge 352.The top edges 354 of the sheets 346 and 348 may be attached to the top340 of the package 342, by for example, adhesive or welding.

It will be noted that the case 212 and the cap 214 are formed as asingle component. This affords the advantage that assembly of multipleparts of the package is not required. Installation of a catheter is allthat is needed to complete the product package assembly.

This product is helpful as it addresses issues that many intermittentcatheter users are experiencing, especially around the areas of hygieneafter use, ease of removal of the catheter and the opening of theproduct. In these criteria the package of the present disclosure issuperior to currently available products, especially in discreet femaleintermittent catheters. For example, a typical intermittent catheteruser is a multiple sclerosis sufferer. Multiple sclerosis sufferers havevarying levels of dexterity and grip strength which can also vary fromday to day in some patients. Having an easy to open package isreassuring that they will always able to void their bladder confidently.

The hygienic re-capture of the catheter into its packaging is also anadvantageous feature of the packaging that other catheters do not fullyaddress; with the flip cap concept of the present disclosure thecatheter can be safely captured after use without fears of spills. Ourcatheter funnel, unlike many prior art funnels, is also able to be usedwith drainage or collection bags made by a variety of manufacturers. Thecollection bag could be attached by a user to an upstanding funnel whilethe catheter is still in the case. The collection bag may have a fittingthat goes inside the funnel. The collection bag could then be detachedfrom the funnel after the used catheter is replaced in the case.

Among the advantages of the present disclosure are: intuitiveness toopen; ease of opening; ease of removal of the catheter from the case;ease of closing of the case after use; discretion and clean to carryafter use; and hygienic use.

An additional embodiment of a package for a urinary catheter is showngenerally at 410 in FIGS. 55-57. The catheter itself is shown generallyat 412 and is best seen in FIG. 56. The catheter has a ribbed funnel 414and tubing 416 press fit into the bottom of the funnel 414 at a centralbore in the funnel. The funnel has a flange 418 extending generallyradially outwardly on its external surface near the bottom of thefunnel. This flange 418 interacts with the internal surface of the caseto assist in retaining the catheter 412 in the package 410. When thecatheter is installed in the package the bottom of the funnel 414 restson the top land of the hydration liner's seat portion 432.

The package 410 includes a container 420 and a cap 422. The cap 422 inthis embodiment is a flip cap that is connected to the container by ahinge and is selectably movable by a user between a closed position,shown in FIG. 56, and an open position. FIG. 55 shows the cap 422 in apartially open position. When the cap 422 is fully open a user hasaccess to the open end of the container 420 for removal or replacementof the catheter 412.

The container 420 in this embodiment is a three-part structure includinga hydration liner 424, a case 426, and a sleeve 428. Each of these threeparts is basically an elongated, hollow tube, closed at the bottom endand open at the top end, with the open top end being selectably openableand closable by the cap 422. The hydration liner 424 fits within thecase 426 which in turn fits within the sleeve 428, as best seen in FIGS.56 and 57.

Details of the hydration liner 424 will now be described. The hydrationliner 424 may be a relatively rigid plastic such as LDPE or HDPE orother suitable material. The liner has a generally hollow tube 430 whichis closed at the bottom. The liner tube 430 may have a slightly conicalshape. The conical shape makes an internal surface of the liner tubewall below the section line visible at 430A in FIG. 57. The walls of thehydration liner's tube 430 also have formed therein one or more passagesor windows 431 (FIG. 57). The windows will be covered with a patch (notshown) of liquid-impermeable but vapor-permeable material such as, butnot limited to, calcium carbonate. The patches will allow passage ofwater vapor for hydration of the catheter but will block passage ofliquid water droplets. The patches may be heat sealed around theperimeter of the window. Thus, the liner 424 defines a space 433 betweenthe liner's exterior surface and the case's interior surface withinwhich a hydration mechanism, such as liquid water may reside. Thispermits hydration of the surface treatment on the catheter tubing 416.

At its upper end the exterior of the liner's tube 430 has a seat portion432 of slightly increased outside diameter compared to the remainder ofthe tube 430. The seat portion 432 is open at its top such that it canreceive the catheter tubing 416. The seat portion 432 hasradially-extending interference ribs 434 formed on the external surfacethereof. In addition to the ribs 434, the external surface of the seatportion 432 has at its top edge a seal 436. The ribs 434 and seal 436are sized to engage the internal wall of the case 426. While the ribs434 engage the internal wall of the case 426 to provide stability, theseal 436 provides a moisture-tight seal against the interior wall of thecase 426. This maintains the hydration mechanism, e.g., liquid water, inthe space 433 between the liner's exterior surface and the case'sinterior surface. It will be understood that in an alternateconfiguration the radially-extending ribs 434 could be formed on theinternal wall of the case instead of on the seat portion 432 of thehydration liner 424. Forming the ribs on the case may make it easier toprotect the ribs after manufacture of the hydration liner and prior toassembly of the package.

Turning now to the details of the case 426, it includes a hollow tube438 the bottom of which terminates at an end wall 440 that closes thebottom of the tube 438. The hollow tube 438 may have either acylindrical or rectangular cross-sectional shape or the cross-sectioncould be otherwise. The upper end of the case 426 flares outwardlysomewhat to increase the diameter of the tube at a neck portion 442. Theneck portion 442 joins a cylindrical ferrule 444 at the top of thehollow tube 438. The ferrule 444 terminates at an open end which definesa rim 446. On the exterior of the ferrule 444 there is a flange 448extending radially outwardly from the ferrule wall. This flange 448interacts with the sleeve 428 as will be explained below. The exteriorof the ferrule 444 also carries a tongue 450 extending radiallyoutwardly from the ferrule wall on the side of the ferrule opposite froma hinge for the cap 422.

The sleeve 428 has a shape reminiscent of that of the case 426 exceptthat the sleeve is somewhat larger than the case such that the case canbe received inside the sleeve. As such the sleeve 428 has a hollow tube452 having a lower, closed end wall 454. Toward the top of the tube 452the sleeve 428 flares outwardly on the right side as seen in FIG. 56 toform a neck portion 456 that encompasses the neck 442 of the case 426.On the right side of FIG. 56 the neck portion 456 terminates just abovethe flange 448 as at junction 458. Thus, the flange 448 is recessedslightly from the end of the sleeve at 458. However, extendingcircumferentially around the sleeve from the junction 458, the upper endof the sleeve extends axially beyond the flange 448 to an increasingdegree. This forms a collar 460 on the open end of the sleeve 428 that,in a side elevation view, slopes diagonally upwardly from a low point atjunction 458 to a high point at the diametrically opposite side of thecollar at 462. In other words, the top land 464 of the sleeve 428extends diagonally to the vertical axis of the sleeve. The top land 464has an outer contour or outer perimeter as would be best seen in a topplan view of the container with the cap removed.

Details of the cap 422 will now be described. The cap 422 as shown isgenerally a two-part structure that includes a generally cup-shapedexternal shell 466 and a liner 476 attached to the interior of the shell466. The shell has a top wall 468 joined to a side wall 470. The sidewall terminates at a generally downwardly facing bottom land 472. Ahinge (not shown) is attached to the side wall 470 and to the case 426.The interior of the shell's side wall 470 also has a groove 474 formedtherein. This groove 474 receives the tongue 450 on the ferrule 444 whenthe cap 422 is closed on the ferrule. The tongue 450 flexes to permitthe tongue to move into and out of engagement with the groove 474 duringclosing or opening. Upon closing the tongue 450 ends up in the groove474. This snap fit closure retains the cap 422 closed until such time asa user wishes to open the cap by pushing the cap upwardly.

The interior of the cap is lined or partially lined with the liner 476which is made of relatively soft material compared to that of the shell466 and case 426. The soft liner 476 promotes a tight seal between thecap 422 and the ferrule 444. This seal is dynamic in the sense that itcan be repeatedly made and broken whenever the user closes or opens thecap 422, respectively. It will be noted the liner 476 may include sprueportions 478 through the side wall 470 of the cap 422. The sprueportions 478 assist in fixing the liner 476 in place and provide a goodgripping surface on the exterior of the cap. The open end of the lineris cylindrical so that it can fit snugly around the external surface ofthe ferrule 444 adjacent to the rim 446 and immediately therebelow. Thisseal is capable of retaining any hydration mechanism in the case. Thebottom land 472 of the side wall 470 of the cap 422 when in the closedposition engages the top land 464 of the sleeve's collar 460. The bottomland has an outer contour that is the same as the outer contour of thetop land 464 of the sleeve's collar 460. That is, the outer perimeter ofa bottom plan view of the bottom land 472 substantially matches theouter perimeter of a top plan view of the top land 464 of the sleeve428. This provides a smooth mating of the exterior surfaces of thesleeve 428 and cap 422, thereby creating a pleasing aesthetic appearanceto the exterior of the closed package.

FIG. 58 illustrates an alternate embodiment for hinging the cap to thecase. In this embodiment the case 426A includes a stand-off wall 480that is separate from the exterior surface of the ferrule 444A. Thestand-off wall 480, while generally curving around the ferrule 444A, isnon-cylindrical, thereby enabling the stand-off wall to define a spaceor gap between itself and the exterior surface of the ferrule 444A. Thetop edge of the stand-off wall 480 joins one end of a hinge 482, theother end of which connects to the cap 422A. The hinge 482 as shown in aliving hinge, but other hinge arrangements could be used. It will beunderstood that a sleeve (not shown but similar to sleeve 428) wouldsurround the case 426A and mate with the underside of the cap 422A.

A further alternate embodiment of the package of the present disclosureis illustrated generally at 522 in FIG. 59. This is a flip cap versionof a package similar to that of the FIGS. 55-58 embodiment in that ithas a container 524 and a flip type cap 526. However, the container 524of FIG. 59 is a two-part structure instead of the three-part structurepreviously shown. The container 524 has a case 528 and a sleeve 530surrounding the case, but there is no hydration liner as in the previousembodiments. Instead, the case 528 has windows 532 each covered with apatch (not shown) of liquid-impermeable but vapor-permeable materialsuch as, but not limited to, calcium carbonate. The patches will allowpassage of water vapor for hydration of a catheter inside the case butwill block passage of liquid water droplets. Thus, the case 528functions like the hydration liner 424 of the prior embodiments. Thecase 528 defines a space 534 between the case's exterior surface and thesleeve's interior surface within which a hydration mechanism, such asliquid water may reside. This permits hydration of the surface treatmenton the catheter tubing 416. While a flip type cap 526 is shown in thisembodiment with a two-part container, it will be understood that a twistcap could also be used.

An alternate version of a liner is shown at 16A in FIG. 60. The liner16A is similar to liner 16 except that the length of the hollow tube istruncated when compared to the hollow tube 78 of FIG. 21. This truncatedversion of the liner may be used where direct hydration of the cathetertubing with liquid water is utilized. The upper portion of the seat ofthe liner 16A will seal against the interior surface of the neck 34C.The catheter tubing will seal against the bottom of the funnel. Afterremoval of the catheter if the case is laid on its side the liner 16Awill prevent leakage of hydration water out the open top of the case.This is because the inside diameter of liner 16A is small enough toprevent drainage of the small amount of water used for hydration. Thatis, with the package on its side, there is not enough hydration water toflood the lowermost wall of a horizontal disposed tube to a depth thatwould leak out through the center of the liner 16A. Thus, the liner 16Aserves as a plug to retain hydration water even when the catheter is notin the package.

FIGS. 61 and 62 illustrate yet another embodiment of the presentdisclosure. This package 124 has a cap and hinge that are essentiallysimilar to those of FIGS. 1-31. Also, package 124 includes a latchmechanism for the cap that includes the interengageable detent, slotsand latches as in FIGS. 1-31. But package 124 differs from the previousembodiments in that it has a two-part case 126 comprising a stem section128 and a flip cap section 130. The upper portion 132 of the stemsection 128 extends through and fits tightly within an opening in theflip cap section 130. The vertical axis of the opening in the flip capsection is shown at axis C. The lower portion 134 of the stem section128 is exposed as it extends below the flip cap section 130. The stemsection and flip cap section are fixed to one another by a suitabletechnique such as welding, adhesive or a snap fit.

The lower portion 134 of the stem section is seen in FIG. 61. Similar tothe case 12, the lower portion 134 has a hollow, tubular wallterminating at an end wall 136. The hollow, tubular wall of the lowerportion 134 may have a generally rectangular cross section as in tubularwall 26. However, in the vicinity of the bottom of the flip cap section130 the tubular wall of the lower portion 134 gradually merges to acircular cross section such that the upper portion 132 of the stemsection 128 has a circular cross section that fits snugly inside theopening through the flip cap section 130, as seen in FIG. 62. Thus, thevertical axis of the lower portion 134 and most of the upper portion 132coincides with axis C. The circular cross section of the upper portion132 ceases at the top end of the stem section at a bowed out portion 138that extends toward the front of the case 126. The underside of thebowed out portion 138 engages a ledge formed on the interior of the flipcap section to limit relative axial movement between the flip capsection and the stem section. The external axial surface of the bowedout portion 138 defines a root 140 of an O-ring groove. The bowed outportion terminates at a radial, upper flange 142 of an O-ring groove.The internal surface of the stem section may have one or more notches asat 144 for locating a hydration liner 16 or a funnel 24.

Looking now at the flip cap section 130, it is noticeably similar to theupper portion of the case 12 in that it includes a body portion have aneck 146 that merges with a generally cylindrical collar 148. The collarand neck define an internal opening therethrough that receives the stemsection as described above. The collar 148 terminates at a shoulder 150and a detent 152. Between them the shoulder and detent define a pair ofslots, one of which is seen at 154 in FIG. 61, each of which receives alatch, one of which is seen at 156, on the bottom of a cap 158. The capis connected to the collar 148 by a hinge 160. With the exception thatthese flip cap components are not integral with the tubular wall of thestem section 128, the foregoing components are essentially the same asthe corresponding components of FIGS. 1-31 and they operate in the samemanner as described above.

The flip cap section 130 also includes a cylindrical, axial projection162, which, as seen in FIG. 62, is indented slightly from the outsidediameter of the collar 148. The amount of the indentation is sufficientto receive the wall thickness of the cap 158. The projection 162 definesa vertical axis D. It will be noted that axis D is laterally offset fromaxis C. This affords the same advantage in terms of clearance betweenthe cap and funnel as described above in connection with axes A and B ofFIG. 36. The top land of the projection 162 defines a lower flange of anO-ring groove. Thus, an O-ring groove is defined by the upper flange142, the root 140 and the lower flange of projection 162. The O-ringgroove receives an O-ring (not shown here but the same as O-ring 20)that seals against the internal surface of the cap 158 when the cap isclosed and thus prevents any leakage from the package 124. It can beseen that since the upper and lower flanges 142, 162 of the O-ringgroove are formed on different parts, there will be no mold parting lineon the root 140 of the O-ring groove.

It should be understood that various changes and modifications to thepresently preferred embodiments described herein will be apparent tothose skilled in the art. Such changes and modification can be madewithout departing from the spirit and scope of the invention disclosedherein. For example, while the outside or exterior contours of thecollar and cap are circular, it could be otherwise so long as each piecehas the same contour at the location where they meet one another whenthe cap is closed. Also, while the case insert is shown mounted in thecase, it will be understood that the location of the insert could beswitched to place it in the cap. The projection of the insert would thenextend axially beyond the bottom land of the cap. The projection wouldagain carry an O-ring to seal against the interior surface of thecollar. Thus, the use of the term “case insert” herein does not requirethat the insert be located in the case. In a similar vein, while theembodiments shown have the latches on the cap and the slots forreceiving the latches on the case, the positions of these parts could bereversed such that the latches are on the case and the receiving slotsis on the cap. Also, while two latches are shown, a different numbercould be present.

What is claimed is:
 1. A medical device package, comprising: a casehaving a hollow tube which is closed at one end and open at the otherend; a cap; a hinge having one end connected to the cap and a second endconnected to said other end of the hollow tube, the hinge permittingselectable movement of the cap between an open position, wherein accessis provided to the open end of the hollow tube, and a closed position,wherein the cap prevents access to the open end of the hollow tube; anda seal connected to at least one of the cap and case, the seal beingengageable with the other of the cap and case when the cap is in theclosed position to form a barrier between the cap and case thatmaintains a sterile environment inside the case and cap.
 2. The medicaldevice package of claim 1 wherein the case includes a projection at theopen end of the case, the projection having a cylindrical exterior, andthe cap includes a shell having a cylindrical interior that receives theprojection therein when the cap is in the closed position.
 3. Themedical device package of claim 2 wherein the seal is connected to theexterior of the projection where the seal is engageable with theinterior of the shell portion when the cap is in the closed position. 4.The medical device package of claim 2 wherein the seal is connected tothe interior of the shell where the seal is engageable with the exteriorof the projection when the cap is in the closed position.
 5. A medicaldevice package, comprising: a case having a hollow tube which is closedat one end and open at the other end; a cap; a hinge having one endconnected to the cap and a second end connected to said other end of thehollow tube, the hinge permitting selectable movement of the cap betweenan open position, wherein access is provided to the open end of thehollow tube, and a closed position, wherein the cap prevents access tothe open end of the hollow tube; and a seal connected to at least one ofthe cap and case, the seal being engageable with the other of the capand case when the cap is in the closed position to form a seal betweenthe cap and case that can be repeatedly made and broken whenever theuser closes or opens the cap, respectively.
 6. The medical devicepackage of claim 5 wherein the case includes a projection at the openend of the case, the projection having a cylindrical exterior, and thecap includes a shell having a cylindrical interior that receives theprojection therein when the cap is in the closed position.
 7. Themedical device package of claim 6 wherein the seal is connected to theexterior of the projection where the seal is engageable with theinterior of the shell portion when the cap is in the closed position. 8.The medical device package of claim 6 wherein the seal is connected tothe interior of the shell where the seal is engageable with the exteriorof the projection when the cap is in the closed position. 9.-22.(canceled)
 23. A medical device package, comprising: a case having ahollow tubular wall which defines an interior and an axis and is closedat one end, the other end of the tubular wall extending to a collarwhich terminates at a top land to define an open end of the collar, thetop land having an external shape and dimension; a cap having a sidewall which defines an interior of the cap and terminates at a bottomland, the bottom land having an external shape and dimension whichmatches that of the top land; a hinge having one end connected to thecap and a second end connected to said collar, the hinge permittingselectable movement of the cap between an open position, wherein accessis provided to the open end of the collar, and a closed position,wherein the cap prevents access to the open end of the collar andwherein the top and bottom lands engage one another in facing relation;at least one latch formed on one of the case and cap; and at least oneslot formed in the other of the case and cap, the latch and slot beingengageable with one another when the cap is closed.
 24. The medicaldevice package of claim 23 wherein the latch has at least one undercutwhich defines a tab.
 25. The medical device package of claim 24 whereinthe slot defines at least one ear, the tab and ear being disposed so asto flex past one another during an opening or closing movement of thecap.
 26. The medical device package of claim 23 further comprising asecond latch and each latch has an undercut which defines a pair oftabs.
 27. The medical device package of claim 26 further comprising asecond slot which together with the first slot defines a detent having apair of ears, the tabs and ears being disposed so as to flex past oneanother during an opening or closing movement of the cap.
 28. Themedical device package of claim 27 wherein the detent is T-shaped. 29.(canceled)
 30. A medical device package, comprising: a case having ahollow tubular wall which defines an interior and an axis and is closedat one end, the other end of the tubular wall extending to a collarwhich terminates at a top land to define an open end of the collar, thetop land having an external shape and dimension; a cap having a sidewall which defines an interior of the cap and terminates at a bottomland, the bottom land having an external shape and dimension; a hingehaving one end connected to the cap and a second end connected to saidcollar, the hinge permitting selectable movement of the cap between anopen position, wherein access is provided to the open end of the collar,and a closed position, wherein the cap prevents access to the open endof the collar, the external shapes and dimensions of the top and bottomlands being such that at least portions of the top and bottom lands willengage one another in facing relation when the cap is closed; at leastone latch formed on one of the case and cap and projecting from the landof said one of the case and cap, the projection of the latch having anaxial component; and at least one slot formed in the other of the caseand cap to define a detent, the detent having an axial component, theslot receiving the latch to place the axial components of the latch anddetent adjacent one another in facing relation when the cap is closed toprevent tangential or circumferential movement of the closed caprelative to the case.
 31. The medical device package of claim 30 furthercomprising: a second latch on said one of the case and cap andprojecting from the land of said one of the case and cap, the projectionof the second latch having an axial component; and a second slot formedin the other of the case and cap to define a second axial component ofthe detent, the second slot receiving the second latch to place theaxial components of the second latch and second detent adjacent oneanother in facing relation when the cap is closed to prevent tangentialor circumferential movement of the closed cap relative to the case.32.-86. (canceled)
 87. An assembly of a catheter and a package therefor,comprising: a case having a closed end and an open end that has anopening defined by a terminal a rim; a cap being selectably movablebetween an open position wherein access is provided to the opening atthe open end of the case and a closed position wherein the cap seals theopening at the open end of the case; and a catheter contained within thecase and being releasably engaged with an interior surface of the caseso as to releasably retain the catheter in the case such that when thecap is in the open position, the catheter is releasably retained in thecase so as to resist inadvertent removal of the catheter.
 88. Theassembly of claim 87 wherein the cap is connected to the case by ahinge.
 89. The assembly of claim 87 wherein the catheter includes acatheter tube and a funnel wherein the funnel is releasably engaged withthe interior surface of the case.
 90. The assembly of claim 89 whereinthe funnel includes a flange that is releasably engaged with a rib onthe interior surface of the case.
 91. The assembly of claim 87 wherein adistal portion of the catheter extends axially beyond the rim and isexposed when the cap is in the opened position.
 92. The assembly ofclaim 91 wherein the distal portion of the catheter comprises a funnel.93. (canceled)
 94. A medical device package, comprising: a containerhaving an open end for receiving a medical device, said open enddefining an outer contour; a cap engageable with the open end of thecontainer and movable between an open position, wherein access isprovided to the open end of the container, and a closed position,wherein the cap prevents access to the open end of the container, thecap having an outer contour which matches the outer contour of thecontainer to provide a continuous outer surface of the package at thejunction of the cap and container when the cap is in the closedposition. 95.-96. (canceled)
 97. The medical device package of claim 94further comprising a hinge connected to the container and to the cap,the hinge permitting selectable movement of the cap between the openposition and the closed position. 98.-100. (canceled)
 101. A medicaldevice package, comprising: a case having an open end for receiving amedical device, the case having a tubular wall with an internal surfacedefining an internal diameter; a cap engageable with the open end of thecontainer and movable between an open position, wherein access isprovided to the open end of the container, and a closed position,wherein the cap prevents access to the open end of the container, ahydration liner having a seat sized to engage the internal surface ofthe tubular wall of the case, the hydration liner further including ahollow tube attached to the seat and extending therefrom to an open end,the hollow tube having an outside diameter less than the internaldiameter of the tubular wall of the case. 102.-108. (canceled)